BioValidity Assists Food Industry Clients With Regulatory Research Needs In Wake of FDA Letter to Industry Regarding Supplements.

Business Editors

LANSDALE, Pa.--(BUSINESS WIRE)--Feb. 8, 2001

The U.S. Food and Drug Administration (FDA) recently issued a letter to the food industry restating the requirements of the Federal Food, Drug, and Cosmetic Act regarding the marketing of conventional foods containing novel ingredients, including botanicals.

To assist in meeting regulatory requirements, a growing number of Fortune 500 food industry clients are turning to BioValidity's BioNutritional Encyclopedia(R) (BNE) for up-to-date, scientifically-validated research information regarding botanicals and other food supplements, according to Dr. David Hamlin, President and CEO of BioValidity, of Lansdale, PA.

In issuing the letter, the FDA reminded manufacturers about the legal requirements regarding claims on conventional foods. FDA must review health claims and nutrient content claims prior to marketing, unless the claim has been authorized by regulation or by statute.

"BioValidity's BNE was designed as a research tool to assist food manufacturers, food supplement producers, and others to obtain current research information on health claims associated with food supplements," said BioValidity's Dr. Hamlin. "We have a university-based Research Team that continually evaluates health benefit claims associated with food supplements, and an Advisory Board of internationally-known industry experts who review and grade material to reflect the level of research."

In a statement dated Feb. 5, the FDA said it was "concerned that some botanical and other novel ingredients that are being added to conventional foods are neither approved food additives, nor generally recognized as being safe for these uses." The FDA said it issued this letter because of "the significant growth in the marketing of foods containing these ingredients." The full announcement is available on the FDA web site at http://www.fda.gov/.

The FDA also reminded manufacturers about the legal requirements regarding claims on conventional foods. The Food Drug and Cosmetic Act allows for certain claims such as:

-- Health claims -- a claim characterizing the relationship between a food
substance and a disease or health related condition;

-- Nutrient content claims -- a claim characterizing the level of a nutrient in
a food;

-- Structure/function claims -- a claim characterizing the effect of a food on
the structure or function of the body.

BioValidity's BioNutritional Encyclopedia(R) provides research information related to health benefit claims associated with more than 240 food supplements (including botanicals, herbs, vitamins, minerals, amino acids, and other additives) as well as over 100 health concerns and 18 body systems. The content reflects the review of over 55,000 journal studies and articles and contains more than 800 scientifically supported benefit statements.

BioValidity -- headquartered in Lansdale, PA -- has developed customized KnowledgeBases for the nutraceutical, life science, and food industries since 1996. Popular products include the BioNutritional Encyclopedia(R) and the Pet Nutrition Knowledgebase, which are used by a number of Fortune 500 clients and others worldwide.

BioValidity is an independent, for-profit, research and consulting firm. Its products are not associated with or endorsed by the FDA or any other government agency.

For further information about BioValidity, please visit www.biovalidity.com or call 888/355-4255. A demonstration version of the BioNutritional Encyclopedia(R) is available at www.biovalidity.com/demo.